BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22371447 · Received July 1, 2025

    Report

    Report Number
    9617229-2025-10913
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    August 1, 2020
    Report Date
    July 1, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607278
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2020-18387. CLARIFICATION TO B3: PARTIAL DATE OF (B)(6) 2020 PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE IV; APPROPRIATE TERM/CODE NOT AVAILABLE (RECALL).

    Description of Event or Problem · 0

    PATIENT REPORTED "GRADE II CAPSULAR CONTRACTURE" AND "SOME DISCOMFORT". PATIENT LATER REPORTED "PRESENCE OF PARTIAL ADIPOSE REPLACEMENT", "CYSTIC NODULE WITH SLIGHTLY DENSE CONTENT IN THE SUBCUTANEOUS PLANE" AND "PROBABLE CYST IN LEFT AXILLA" VIA US. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE IV CAPSULAR CONTRACTURE". LEGAL REPRESENTATIVE LATER REPORTED "CAPSULAR CONTRACTURE GRADE IV" VIA US AND MRI, "RECALL OF THE NATRELLE PROSTHESIS", "RECALL OF THE COMPANY", "LOT OF PAIN", "DISCOMFORT", "BREASTS ARE DEFORMED", "PATIENT HAS A GENETICAL CONDITION TO DEVELOP THE LYMPHOMA", "FAMILY HISTORY OF THE DISEASE", "RECALL MADE THE PATIENT FEEL ANGUISH", "SO MUCH WORRY", "PAIN", "ENCAPSULATED PROSTHESIS", "OUT OF PLACE", "RISK OF LYMPHOMA", "SEVERAL ANXIETY ATTACKS", "PANIC ATTACKS", "FEAR OF DYING", "UNDERGOING PSYCHIATRIC TREATMENT", "PATIENT WAS PHYSICALLY AND PSYCHOLOGICALLY HARMED", "CONTRACTURE PAINS", "ANGUISH", "TRAUMAS", "ANXIETY BEHAVIOR", "PANIC", "DEATH WISH", "DIFFICULTY IN ATTENTION", "CONCERN ABOUT THE RISK OF DEVELOPING SOME TYPE OF ALTERATION IN THE HEALTH OF HER BREASTS DUE TO THE RECALL INFORMATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206150 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2494986 5060191607278

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention